ri-scope® retinoscope head slit XL 3.5 V, 10544-301

GUDID 04045396129931

The slit/spot retinoscopes (also known as skiascopes) are produced to determine the refraction (ametropias) of the eye.

Rudolf Riester GmbH

Retinoscope, battery-powered Retinoscope, battery-powered Retinoscope, battery-powered Retinoscope, battery-powered Retinoscope, battery-powered Retinoscope, battery-powered Retinoscope, battery-powered Retinoscope, battery-powered Retinoscope, battery-powered Retinoscope, battery-powered

• Primary Device ID: 04045396129931
• NIH Device Record Key: b386d14e-efd3-479d-b714-4cd873d1b5a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ri-scope® retinoscope head slit XL 3.5 V,
• Version Model Number: 10544-301
• Catalog Number: 10544-301
• Company DUNS: 537208717
• Company Name: Rudolf Riester GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04045396129931 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K964338

FDA Product Code

• HKM: Retinoscope, Battery-Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-05
• Device Publish Date: 2021-01-28

Devices Manufactured by Rudolf Riester GmbH

• 04045396007017 - Pack of 6 pcs. ri-pen® red: 2021-07-27 The Riester diagnostic light is used for ophthalmological examination.
• 04045396120310 - ri-pen® blue: 2021-07-27 The Riester diagnostic light is used for ophthalmological examination.
• 04045396120341 - ri-pen® green: 2021-07-27 The Riester diagnostic light is used for ophthalmological examination.
• 04045396120389 - ri-pen® silver: 2021-07-27 The Riester diagnostic light is used for ophthalmological examination.
• 04045396120464 - ri-pen® black: 2021-07-27 The Riester diagnostic light is used for ophthalmological examination.
• 04045396120525 - ri-pen® red: 2021-07-27 The Riester diagnostic light is used for ophthalmological examination.
• 04045396198487 - e-xam XL 2.5 V, black: 2021-07-27 The Riester diagnostic light is used for examination.
• 04045396198562 - Pack of 6 pcs. ri-pen®, violett: 2021-07-27 The Riester diagnostic light is used for ophthalmological examination.